Wednesday, July 27, 2011

FDA Proposes Guidelines for Medical Apps

The Food and Drug Administration (FDA) recently proposed guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps do not work as intended.

The agency has already cleared a handful of mobile medical apps used by health care professionals, such as a smartphone-based ultrasound app and an app for iPhones and iPads that allows physicians to view medical images and x-rays.

The agency now is proposing to oversee mobile medical apps that are used as an accessory to an FDA-regulated medical device, such as an app that could enable a health care professional to view medical images on an iPad and make a diagnosis. The guidelines also would cover apps that transform a mobile platform into a regulated medical device. An example would be an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.